NCT05288647

Brief Summary

This study is designed to evaluate the clinical outcomes of computer-guided sodium hyaluronate injection in superior joint space in comparison to conventional injection for treatment of intra-articular TMJ disorder.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 24, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 7, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 11, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 11, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 21, 2022

Completed
Last Updated

March 31, 2022

Status Verified

March 1, 2022

Enrollment Period

1.3 years

First QC Date

March 11, 2022

Last Update Submit

March 18, 2022

Conditions

TMD

Keywords

TMD

Outcome Measures

Primary Outcomes (3)

  • Comparison of maximum unassisted mouth opening range

    Opening range determined by asking the patient to gently open the mouth and measure the distance between upper and lower central incisor using an vernier digital electronic caliper. Vertical movement of the mandible corrected by adding the vertical overlap.

    6 months

  • Comparison of modified Helkimo's clinical dysfunction index.

    A modified version of Helkimo's clinical dysfunction index calculated to assess the TMJ dysfunction.

    6 months

  • Comparison of pain intensity on Visual analog scale

    Patients asked to mark their TMJ-related pain level on a scale from 0 to 10, where 0 is "no pain" and 10 is "severe pain".

    6 months

Secondary Outcomes (2)

  • Total procedural time.

    Baseline

  • Patient convenience.

    Baseline

Study Arms (2)

Group A

EXPERIMENTAL

Patients treated with four computer-guided sodium hyaluronate injections in superior TMJ space.

Procedure: TMJ injection

Group B

ACTIVE COMPARATOR

Patients treated with four conventional sodium hyaluronate injections in superior TMJ space.

Procedure: TMJ injection

Interventions

TMJ injectionPROCEDURE

four sodium hyaluronate injections in superior TMJ space

Group AGroup B

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients diagnosed with intra-articular TMJ disorder according to Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD).
  • Patients who would not respond to conservative treatment as the first line of treatment.

You may not qualify if:

  • Patients with polyarthritis or degenerative joint disease.
  • Patients with myofascial pain.
  • Previous history of minimally invasive or invasive treatment of TMJ.
  • History of mandibular fracture.
  • Lactating, pregnant or planning pregnancy women.
  • Known hypersensitivity to hyaluronic acid or clear biocompatible photopolymer resin.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry, Al-Azhar University.

Cairo, 11884, Egypt

Location

Related Publications (3)

  • Krause M, Dorfler HM, Kruber D, Humpfner-Hierl H, Hierl T. Template-based temporomandibular joint puncturing and access in minimally invasive TMJ surgery (MITMJS) - a technical note and first clinical results. Head Face Med. 2019 Apr 2;15(1):10. doi: 10.1186/s13005-019-0194-8.

    PMID: 30940211BACKGROUND

  • Steenks MH, Turp JC, de Wijer A. Reliability and Validity of the Diagnostic Criteria for Temporomandibular Disorders Axis I in Clinical and Research Settings: A Critical Appraisal. J Oral Facial Pain Headache. 2018 Winter;32(1):7-18. doi: 10.11607/ofph.1704.

    PMID: 29370321BACKGROUND

  • Rani S, Pawah S, Gola S, Bakshi M. Analysis of Helkimo index for temporomandibular disorder diagnosis in the dental students of Faridabad city: A cross-sectional study. J Indian Prosthodont Soc. 2017 Jan-Mar;17(1):48-52. doi: 10.4103/0972-4052.194941.

    PMID: 28216845BACKGROUND

Study Officials

  • AbdElKader A Hyder, MSc

    Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Al-Azhar University

    PRINCIPAL INVESTIGATOR

  • Wael A ElMohandes, PhD

    Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Al-Azhar University

    STUDY DIRECTOR

  • Bahaa El-Din A Tawfik, PhD

    Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Al-Azhar University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 11, 2022

First Posted

March 21, 2022

Study Start

December 24, 2019

Primary Completion

April 7, 2021

Study Completion

October 11, 2021

Last Updated

March 31, 2022

Record last verified: 2022-03

Locations

EG(1)